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EC number: 221-259-8 | CAS number: 3048-64-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted to GLP with full study report available
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15-23 g
- Housing: Individually housed in suspened polypropylene cages with stainless steel mesh lids on softwood flake bedding
- Diet: Certified rat and mouse diet from an accredited supplier, ad libitum
- Water : mains tap water ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 Celsius (target)
- Humidity (%): 30 - 70 target
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: - No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Number of animals: 1:
- Protocol: Daily application of 25ul to dorsal surface of each ear for 3 consecutive days.
- Irritation: none observed.
MAIN STUDY
- Criteria used to consider a positive response: 3 fold increase in dpm
TREATMENT PREPARATION AND ADMINISTRATION: Mice treated with undiluted test material or at concentrations of 25 and 50% in acetone/olive oil (4:1). Daily application of 25ul to the dorsal surface of each ear for 3 consecutive days. Five days following first topical application (Day 6) all mice injected via the tail vein with 250ul of phosphated buffer saline containing 3H-methyl thymidine giving a total dose of 20uCi to each mouse. - Parameter:
- SI
- Remarks on result:
- other: Vehicle: na 25%v/v: 2.16 (Negative) 50%v/v: 3.42 (Positive) 100% v/v: 7.22 (Positive)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle: 891.54/node 25% v/v: 1929.52/node 50% v/v: 3052.52/node 100% v/v: 6440.82/node
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- ENB is a sensitizer as at last one concentration resulted in a 3-fold or greater increase in tritiated TdR incorporation compared with controls
- Executive summary:
In a guideline LLNA study conducted under GLP, 5-ethylidene-norborn-2-ene was shown to be a sensitizer at 50% v/v and neat. The result suggest that ENB is a weak sensitiser. This result can be considered representative of the likely sensitising potential of the close structural analogue vinyl norbornene.
Reference
The concentration of the tested substance ENB expected to cause a 3-fold increase in 3HTdR incorporation was calculated to be 41.7% v/v in acetone/olive oil 4:1.
The results suggest that ENB is a weak sensitiser.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In a guideline LLNA study conducted under GLP, 5-ethylidene-norborn-2-ene was shown to be a sensitizer at 50% v/v and neat. The result suggest that ENB is a weak sensitiser. This result can be considered representative of the likely sensitising potential of the close structural analogue vinyl norbornene.
Justification for selection of skin sensitisation endpoint:
Only study in dossier
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results from a mouse LLNA study indicate that the close structural analogue ethylidene norbornene should be classified as a skin sensitiser. The quantitative data indicate that the response is weak and, according to the recommendations of ECETOC ("Contact Sensitisation: Classification according to potency", Technical Report 87, 2003) such a response would justify a classification limit for mixtures of 3% rather than the default of 1%. This result can be considered representative of the likely sensitisation potential of vinyl norbornene and therefore the conclusions regarding classification would also apply to the latter.
There is no data on respiratory sensitisation.
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